ISO 9000 Quality Systems Handbook - PQM-online

1 ISO 9000 Quality SystemsHandbookISO 9000 Quality SystemsHandbookFourth EditionCompletely revised in response to ISO 9000 :2000 David HoyleOXFORD AUCKLAND BOSTON JOHANNESBURG MELBOURNE NEW DELHIB utterworth-HeinemannLinacre House, Jordan Hill, Oxford OX2 8DP225 Wildwood Avenue, Woburn, MA 01801-2041A division of Reed Educational and Professional Publishing LtdA member of the Reed Elsevier plc groupFirst published 1994 Second edition 1994 Third edition 1998 Reprinted 1999 Fourth edition 2001 David Hoyle 2001 All rights reserved. No part of this publication may be reproduced inany material form (including photocopying or storing in any medium byelectronic means and whether or not transiently or incidentally to someother use of this publication) without the written permission of thecopyright holder except in accordance with the provisions of the Copyright,Designs and Patents Act 1988 or under the terms of a licence issued by theCopyright Licensing Agency Ltd, 90 Tottenham Court Road, London,England W1P 0LP.

2 Applications for the copyright holder s writtenpermission to reproduce any part of this publication should be addressedto the publishersBritish Library Cataloguing in Publication DataA catalogue record for this book is available from the British LibraryLibrary of Congress Cataloguing in Publication DataA catalogue record for this book is available from the Library of CongressISBN 0 7506 4451 6 For information on all Butterworth-Heinemann publications visit our website by Genesis Typesetting, Laser Quay, Rochester, KentPrinted and bound in Great BritainContentsPrefaceixChapter 1 Introduction1 Chapter 2 Basic concepts18 Principles or prescription18 Quality19 The interested parties22 The characteristics of quality25 Achieving sustaining and improving quality32 Summary76 Basic concepts Food for thought77 Chapter 3 Role, origins and application of ISO 900080 The role of ISO 900080 Origin of ISO 900083 Changes to ISO 900091 Exclusions102An alternative structure106 Certification to ISO 9001.

3 2000111 Summary113 Role, origins and application Food for thought114viContentsChapter 4 Quality management system116 Summary of requirements116 Establishing a Quality management system117 Identifying processes ( )121 Sequence and interaction of processes ( )127 Criteria and methods for effective operation andcontrol ( )128 Documenting a Quality management system ( , )130 Documented procedures ( )137 Documents that ensure effective planning, operationand control of processes ( )140 Implementing a Quality management system ( )158 Managing processes ( )159 Ensuring information availability ( )164 Ensuring the availability of resources ( )166 Measuring, monitoring and analysing processes ( )167 Maintaining a Quality management system ( )170 Continual improvement in the QMS and itsprocesses ( and )172 Preparing the Quality manual ( )174 Control of documents ( )180 Control of records ( and )207 Summary217 Quality Management System Questionnaire218 Quality Management System Food for Thought219 Chapter 5 Management responsibility222 Summary of requirements222 Management commitment ( )223 Customer focus ( )236 Quality policy ( )242 Quality objectives ( )251 Quality management system planning ( )

4 261 Responsibility and authority ( )267 Management Representative ( )273 Internal communication ( )280 Management Review ( )284 Summary297 Management Responsibility Questionnaire297 Management Responsibility Food for Thought299 Chapter 6 Resource management302 Summary of requirements302 Determining resources ( )304 ContentsviiProviding resources ( )307 Competence of personnel ( )310 Training, awareness and competence ( )314 Infrastructure ( )329 Work environment ( )336 Summary349 Resource Management Questionnaire350 Resource Management Food for thought351 Chapter 7 Product realization353 Summary of requirements353 Planning product realization processes ( )356 Customer-related processes ( )376 Design and development ( )401 Purchasing ( )449 Production and service provision ( )473 Control of measuring and monitoring devices ( )510 Summary534 Product Realization Questionnaire535 Product Realization Food for Thought540 Chapter 8 Measurement, analysis and improvement542 Summary of requirements542 Monitoring, measurement, analysis and improvementprocesses ( )544 Customer satisfaction ( )

5 553 Internal audit ( )556 Monitoring and measurement of processes ( )572 Monitoring and measurement of product ( )576 Control of nonconforming product ( )584 Analysis of data ( )595 Improvement ( )609 Summary640 Measurement, analysis and improvement questionnaire641 Measurement, analysis and improvement food forthought644 Appendix A Glossary647 Appendix B Related web sites658 Index661 Preface and acknowledgementsSince the third edition of this Handbook was published in 1998 there has beena radical change to the ISO 9000 family of standards. The standards havechanged in structure from 20 elements to 8 sections; they have changed inintent from Quality assurance to customer satisfaction; the terminology haschanged so as to suit all types of organizations and there has been a change indirection from a focus on planning, inspection and test and the removal ofnonconformity to a focus on objectives, processes, measurement, analysis meant that the Handbook that had evolved over the previous eight yearsrequired a complete rewrite.

6 However, I have maintained the basic purpose ofthe Handbook that of providing the reader with an understanding of eachrequirement of ISO 9001 through explanation, examples, lists, tables anddiagrams. As there were over 300 requirements in the 1994 version of ISO 9001,this led to a book of considerable size it was not intended as a quick read! Itwas and remains a source of reference and although I was tempted torestructure the book as an A-Z of ISO 9000 to reduce duplication, I haveadhered to following the structure of the standard, adding clause numbers tothe headings to make it user-friendly. The Handbook is therefore laid out so asto follow the section numbers of ISO of the requirements of the 1994 version are included in the 2000 versionof ISO 9001, but few remain exactly the same.

7 Many have been reworded orcondensed to remove over-prescriptive requirements and focus on generalconcepts. The differences between the 1994 and 2000 versions are shown in textxPreface and acknowledgementsboxes by the side of the new requirement. In revising this Handbook a lot ofdetail had to be omitted primarily as it was focused on manufacturingexamples or detail requirements that are no longer included in the versions of this Handbook therefore remain relevant and a usefulsource of information for those interested in seeking such the previous editions the approach taken was to identify a requirement andthen explain its meaning followed by some examples to illustrate how it could beimplemented.

8 In this new edition I have followed a more structured approachand for each requirement answered three basic questions: What does it mean? Whyis it important? How is it implemented?This is so that the requirements may beperceived as reflecting concepts valid outside the context of ISO the end of each chapter there is a Questionnaire built from therequirements of the standard. It is not intended that these questions be used byauditors but by users of the standard in order to test the completeness of thesystem they have formalized. In place of the lists of do s and don ts and thetask list of previous editions, I have included a section on Food for intended to cause the reader to reflect on the previous chapter, perhaps evenchange perceptions but mostly confirm understanding.

9 The do s and don tsand task lists are within the text and will be consolidated in a new edition ofthe ISO 9000 Pocket the book a common approach has been taken to the require-ments of ISO 9000 . This approach is a development of that what was used inthe previous editions. The standard has become more generic, it now presentsthe requirements in a more user-friendly format and has adopted the processapproach to management. While the requirements of ISO 9001 are expressed ina way that takes the reader through a cycle starting with the Quality policy,leading onto Quality objectives and ending with performance being reviewedagainst objectives, there remain many inconsistencies that could lead toconfusion.

10 Many of the linkages between policy, objectives, processes andresults are inferred they are not expressed unambiguously. It is only bystudying ISO 9000 , ISO 9001 and ISO 9004 and searching for understandingthat a clear logic emerges. The use of the word qualitycreates an anomaly andtends to represent the standard as simply a tool to meet customer qualityrequirements and no others. This is not to say that the standard is flawed. It isonly saying that the concepts could be presented more clearly. Consequently Ihave taken an approach that requires the principles and requirementscontained in the ISO 9000 family to be perceived as general business conceptsand not simply limited to the achievement of qualityin its narrowest the arguments for taking this approach are addressed in the book.